Premature Infants in Need of Transfusion (PINT)
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About
Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly).
Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.
Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.
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Inclusion criteria
- birth weight <1000g
- postnatal age <48 hours
- no transfusion beyond first 6 hours of life
- estimated gestational age of 30 completed weeks or less
Exclusion criteria
- infant considered non-viable by attending physician
- infant has cyanotic congenital heart disease
- infant's parents known to be opposed to blood transfusion
- either parent has hemoglobinopathies or congenital anemias
- infant has hemolytic disease
- infant has severe acute hemorrhage, severe shock, severe sepsis with coagulopathy or requires peri-operative transfusion
- prior treatment with or intention to treat with erythropoietin
Trial design
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Interventional model
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Data sourced from clinicaltrials.gov
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